The QMN Weekly Bulletin

Switching from paper-based quality systems to integrated, electronic systems could lower recall costs for devicemakers, a quality system expert says.

The FDA is conducting a pilot program aimed at increasing communications between drug reviewers and inspectors in its preapproval inspections (PAI) program, according to an agency director.

As devicemakers increase their dependence on third-party suppliers and contractors, focusing on quality instead of costs is not only good for regulatory compliance purposes but also makes good business sense, according to a former FDA associate commissioner and industry consultant.

Pfizer will cut 275 jobs from its manufacturing operations in Kalamazoo County before the end of the year.

The government gave its approval to move official amendments to the Drugs and Cosmetics Amendment Bill, 2005, which calls for harsh punishments to persons involved in manufacture and sale of spurious drugs.

India boasts of over 80 US FDA-approved plants, the largest number in any country other than the US.

The Ministry of Health (MoH) and the Ministry of Trade and Industry (MTI) have vowed to develop and strengthen the country’s pharmaceutical industry and stabilize the drug market in the coming future.

RxElite announced the signing of a ten-year development, supply and marketing agreement with Hi-Tech Pharmacal Co., Inc., a manufacturer and marketer of liquid generic products.

Perrigo Co. plans to invest $10.5 million in its Allegan headquarters and production campus in an expansion that's projected to generate 99 new jobs within a year and 400 over five years.